Allergan Breast Implant Approved by FDA

The Food and Drug Administration has approved a breast implant manufactured by Allergan (NYSE: AGN  ) . The California-based company's Natrelle 410, a silicone-gel filled implant, may now be used for breast reconstruction, augmentation, and revision surgery in women who are at least 22 years of age.

The FDA's approval is conditional. The requirements include mandates for the company to monitor the product's effects on 3,500 patients for a period of five years, analyze the Natrelles that are removed from patients and returned to the firm, and evaluate patient perceptions of the product's labeling.

The FDA said that, with this decision, there are now four silicone gel breast implant products approved in the U.S.


Read/Post Comments (0) | Recommend This Article (0)

Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

Be the first one to comment on this article.

Sponsored Links

Leaked: Apple's Next Smart Device
(Warning, it may shock you)
The secret is out... experts are predicting 458 million of these types of devices will be sold per year. 1 hyper-growth company stands to rake in maximum profit - and it's NOT Apple. Show me Apple's new smart gizmo!

DocumentId: 2270742, ~/Articles/ArticleHandler.aspx, 10/24/2014 12:42:23 PM

Report This Comment

Use this area to report a comment that you believe is in violation of the community guidelines. Our team will review the entry and take any appropriate action.

Sending report...


Advertisement